BOTOX® in the Treatment of Crow's Feet Lines in China

Allergan

Status and phase: Completed; Phase 3

Conditions: Lateral Canthal Lines; Crow's Feet Lines

Treatments: Drug: Normal Saline; Biological: botulinum toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02195687

191622-113

Details and patient eligibility

About

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines).

Enrollment: 417 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Moderate to severe Crow's Feet Lines.

Exclusion criteria

• Current or previous treatment with botulinum toxin of any serotype for any condition within the last year
• Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
• Facial laser or light treatment, microdermabrasion or chemical peels within 3 months
• Radio frequency laser treatments, phototherapy, blepharoplasty, brow-lift or related procedure, permanent make-up, oral retinoid therapy or treatment with non-permanent soft tissue fillers within 1 year
• Any medium-depth or deep facial peels within 5 years
• Periorbital surgery, face-lift, mid facial or periorbital treatment with permanent soft tissue fillers, synthetic implants or autologous fat transplant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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417 participants in 2 patient groups, including a placebo group

botulinum toxin type A

Experimental group

Description:

24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.

Treatment:

Biological: botulinum toxin Type A

placebo

Placebo Comparator group

Description:

Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.

Treatment:

Drug: Normal Saline